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SHAPER No.2 AD-05002

by Timpel S/A

Ref AD-05002-0

SHAPER No.2 AD-05002 is a medical device (EU MDR Class I; FDA Class II; FDA product code QEB, Ventilatory Electrical Impedance Tomograph; EMDN category adapters and connectors) made by Timpel S/A, registered in EUDAMED on 20 Oct 2026 (Basic UDI-DI 7898959841SHAPERDB) and listed in FDA GUDID since 28 Oct 2019 (UDI-DI 07898959841279), active as of 24 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number7898959841SHAPERDB Basic UDI-DI 07898959841279UDI-DIDate20 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07898959841279 UDI-DI Date28 Oct 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 7898959841SHAPERDB registered 20 Oct 2026 Active
  • FDA GUDID UDI-DI 07898959841279 listed 28 Oct 2019 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 07898959841279
  2. Registered EUDAMED 7898959841SHAPERDB

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
ENLIGHT Shaper NR2 EUDAMED
SHAPER No.2 GUDID
Generic name
Electrical impedance skin electrode chest positioner
Device name
Shaper
Model / reference
AD-05002-0 EUDAMED
AD-05002 GUDID
Primary DI / UDI-DI
07898959841279
Basic UDI-DI
7898959841SHAPERDB
Direct marketing DI
07898959841279
FDA product code
QEB
EMDN code
A070199 Adapters and connectors - other
GMDN term
Electrical impedance skin electrode chest positioner
Device class
Class I EUDAMED
Class II GUDID
Regulation number
868.1505
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
AD-05002-0
GUDID
AD-05002
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Electrical impedance skin electrode chest positioner

Similar devices

Also classified as Electrical impedance skin electrode chest positioner.

Similar devices in this category

Other devices filed under ADAPTERS AND CONNECTORS - OTHER.

Other devices from Timpel S/A

See all devices from Timpel S/A →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)